Medtronic plc has received FDA approval for its Affera Mapping and Ablation System with the Sphere-9 catheter, a device designed for the treatment of persistent atrial fibrillation (AFib) and radiofrequency (RF) ablation of cavotricuspid isthmus (CTI) dependent atrial flutter. This approval marks Medtronic as the first company with two pulsed field ablation (PFA) technologies available for AFib patients.
The Affera Sphere-9 catheter features a wide area focal design with a 9 mm lattice tip, compatible with an 8.5Fr sheath, offering physicians flexibility in treatment. The approval is based on data from the SPHERE Per-AF study, which compared the Affera system to the Thermocool SmartTouch SF catheter with the Carto 3 System.
Sphere-9 Catheter Design and Functionality
The Sphere-9 catheter integrates both pulsed field (PF) and radiofrequency (RF) energy delivery within the Affera Mapping and Ablation System. This design aims to improve workflow efficiency while maintaining safety and efficacy. According to Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera, the system allows for a single transeptal, zero-fluoroscopy, and zero-exchange workflow, providing physicians the flexibility to use either pulsed field or radiofrequency energy.
Clinical Impact and Physician Perspective
Vivek Reddy, director of cardiac arrhythmia services for the Mount Sinai Health System, stated that the Affera system is a "game changer" for treating AFib and atrial flutter. He emphasized the system's potential to provide a safe, effective, and efficient solution for this common heart disease, with a short learning curve for experienced physicians.
Medtronic's Broader Strategy in Atrial Fibrillation
This approval follows the FDA approval of Medtronic's PulseSelect Pulsed Field Ablation System in December 2023, which offers a single-shot solution for pulmonary vein isolation (PVI). Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, noted the company's commitment to addressing unmet patient needs through disruptive innovation. The Affera system has also received CE Mark in March 2023 and was approved in Australia in September 2024. Medtronic has initiated an early feasibility study to evaluate the Sphere-9 catheter for treating ventricular tachycardia (VT).
Market Context and Disease Burden
Atrial fibrillation affects over 60 million people worldwide and is a progressive disease that can lead to serious complications such as heart failure, stroke, and increased risk of death. The Affera system aims to provide a safer, more effective, and more efficient treatment option for this prevalent condition.
